- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03029871
Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer (NSCLC)
Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Combination With Stereotactic Body Radiation Therapy (SBRT) in Clinical Stage 1/11A (T1A-T2B) Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of NSCLC.
- Clinical stage I/IIA (T1a - T2b; AJCC Staging 7th edition) with a tumor size > 1 cm to ≤ 6 cm in diameter (long axis) based on the following minimum diagnostic workup:
Note: Subjects may have M0 or MX status (e.g., lung nodules that are being observed). Known M1 disease is excluded. Subjects may have only one target lesion for SBRT.
- Evaluation at lung multi-disciplinary tumor board with recommendation for SBRT within 12 weeks of registration.
- Whole body positron emission tomography (PET/CT) scan within 12 weeks of registration using [18F]-FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions.
Mediastinal lymph node sampling by any technique is allowed but not required. Subjects with > 1.5 cm mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsies of abnormally identified areas are negative for cancer.
- Zubrod Performance Status 0 - 2 with 4 weeks of registration.
- Age ≥ 18.
- Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:
- Adequate renal function with serum creatinine ≤ 1.5 mg/dL or creatinine clearance >50 mL/min/m2.
- Platelet count > 100,000/μL.
- Absolute neutrophil count > 1,000/μL.
- Hemoglobin > 10.0 g/dL.
- Bilirubin > 1.5 mg/dL
- AST/SGOT and ALT/SGPT < 3.0 times upper limit of normal (ULN).
- Negative serum or urine pregnancy test within 72 hours prior to the adenovirus injection for women of childbearing potential.
- Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout and for 60 days beyond the treatment phase of the study.
- Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.
Exclusion Criteria:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (e.g., carcinomas in situ of the breast, oral cavity, or cervix are permissible). Subjects with previous lung cancer are permitted if the subject is disease-free for a minimum of 2 years or if this is a solitary recurrence in the lung measuring > 2 cm and ≤ 5 cm after surgery.
- Any known metastatic disease. Subjects may have MX status (e.g., lung nodules that are being observed).
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Prior chemotherapy for the study cancer.
- Plans for the subject to receive other local therapy (including standard fractionated radiotherapy and/or surgery and/or other local ablative therapies) while on this study, except in the case of disease progression.
- Plans for the subject to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except in the case of disease progression.
- Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that requires specific therapy within 72 hours of initiation of the study therapy.
- Previous history of liver disease including hepatitis.
- Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and topical corticosteroids is permitted.
- Impaired immunity or susceptibility to serious viral infections.
- Allergy to any product used in the protocol.
- Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Nine subjects (3 cohorts, 3 subjects/cohort) with medically inoperable stage I/IIA (T1a - T2b) NSCLC with tumors measuring > 2 to ≤ 5 cm will receive a single intratumoral injection of the oncolytic Ad5-yCD/mutTKSR39rep-ADP adenovirus at one of three dose levels (1 x 1011 vp, 3 x 1011 vp, 1 x 1012 vp).
Depending on the location of the target lesion, the adenovirus will be injected either transbronchially (central tumors) or percutaneously under computed tomography (CT)-guidance (peripheral tumors).
Two days later, subjects will be administered (orally) a 10 day course of 5-fluorocytosine (5-FC) and valganciclovir (vGCV) prodrug therapy along with 48 Gy (4 fractions of 12 Gy) of SBRT.
Prior to and following the adenovirus injection, subjects will be administered [18F]-FHBG, a HSV-1 TK substrate, and will undergo PET imaging to quantify HSV-1 TK gene expression.
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oncolytic adenovirus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity and maximum tolerated dose
Time Frame: 60 days
|
Treatment-related adverse events (CTCAE v4.03)
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60 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: 3 months to 5 years
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RECIST
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3 months to 5 years
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Survival
Time Frame: 3 months to 5 years
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Progression-free and overall
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3 months to 5 years
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Quality of Life
Time Frame: 3 months to 5 years
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FACT-TOI (Functional Assessment of Cancer Therapy-Trial Outcome Index)
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3 months to 5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10835 (Registry Identifier: DAIDS ES Registry Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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